BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDIATRIC BOBBIN VENT TUBE

    MDR report key: 12463519 · Received September 13, 2021

    Report

    Report Number
    1000022662-2021-00002
    Event Type
    Malfunction
    Date Received
    September 13, 2021
    Date of Event
    June 30, 2021
    Report Date
    August 19, 2021
    Manufacturer
    GRACE MEDICAL, INC.
    Product Code
    ETD
    UDI-DI
    00844505002547
    PMA / PMN Number
    K943325
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLAINT REGARDING THIS PART NUMBER AND LOT NUMBER COMBINATION WAS NOT REPORTED TO GRACE MEDICAL, INC. NO PRODUCT WAS RETURNED TO GRACE MEDICAL, INC. FOR EVALUATION. THERE WERE NO PRODUCTS IN FINISHED GOODS INVENTORY WITH THIS PART NUMBER AND LOT NUMBER COMBINATION TO CHECK. THE REVIEW OF THE DEVICE HISTORY RECORDS ASSOCIATED WITH THIS DEVICE AND LOT NUMBER DID NOT FIND ANY NONCONFORMANCE. ADDITIONALLY, THERE HAVE BEEN NO COMPLAINTS FOR THIS PART NUMBER AND LOT NUMBER. LIMITED INFORMATION IS AVAILABLE AT THIS TIME. IF INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING THE REVIEW OF THE MAUDE ADVERSE EVENT DATABASE ON AUGUST 19, 2021, IT WAS DISCOVERED THAT A GRACE MEDICAL, INC. PEDIATRIC BOBBIN VENT TUBE WAS REFERENCED IN MDR REPORT NUMBER 1(B)(4) BY A USER FACILITY, AND RECEIVED BY FDA ON 7/30/2021. THE FOLLOWING EVENT WAS REPORTED BY THE USER FACILITY AS FOLLOWS: MODEL NUMBER: 500-061; (B)(4). EVENT DATE: (B)(6) 2021; EVENT TYPE: MALFUNCTION. EVENT DESCRIPTION: "THE TITANIUM TUBE PLACED IN THE LEFT EAR DRUM FOR A BILATERAL MYRINGOTOMY WITH TUBE PLACEMENT FELL FORWARD INTO THE MIDDLE EAR." THE LOT NUMBER REPORTED IS LOT NUMBER 58580.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1360867 PEDIATRIC BOBBIN VENT TUBE TYMPANOSTOMY TUBE ETD GRACE MEDICAL, INC. 500-061 58580 00844505002547

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention